MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 1973-03

Device Problems Difficult to Remove (1528); Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).

Event Description

It was reported that the balloon failed to deflate and was difficult to remove.The 95% stenosed target lesion was located in moderately tortuous and severely calcified artery.A 6.0 x 60mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for endovascular therapy procedure.During the procedure, the balloon was initially inflated at nominal pressure for 180 seconds.Upon deflation, the balloon did not completely deflate.The balloon was attempted to be deflated for 10 seconds, and upon removal, resistance occurred.The entire system was then removed, and the procedure was completed.No complications were reported.

Event Description

It was reported that the balloon failed to deflate and was difficult to remove.The 95% stenosed target lesion was located in moderately tortuous and severely calcified artery.A 6.0 x 60mm, 135cm ranger paclitaxel-coated pta balloon catheter was selected for endovascular therapy procedure.During the procedure, the balloon was initially inflated at nominal pressure for 180 seconds.Upon deflation, the balloon did not completely deflate.The balloon was attempted to be deflated for 10 seconds, and upon removal, resistance occurred.The entire system was then removed, and the procedure was completed.No complications were reported.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device found that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.The balloon was pulled in a distal direction over the distal tip.The investigator was unable to inflate the balloon due to the damage of the polymer extrusion.The markerbands and tip section of the device were visually examined, and no issues were noted with the markerbands or tip of the device.A visual and tactile examination of the polymer extrusion found multiple kinks.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18908671
• MDR Text Key: 337741154
• Report Number: 2124215-2024-14333
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: 08714729976103
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 04077H22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1